The present invention relates to medical devices and methods of making and operating or using them. In some embodiments, the invention relates to a device and a method for detecting whether a medical device, such as an injection device, an infusion device, a device for measuring the concentration of a specific substance, or any other medical function, delivery or measuring device, is being operated by a person. In some embodiments, the present invention relates to devices and methods for identifying a user or operator of a medical device on the basis of person-specific features such as, for example, biometrics or body-specific features, and to tying the operation or functions of a medical device to the identity of a person.
In the case of medical devices, such as injection devices, insulin pumps, or other substance delivery devices, or devices for performing measurements, it is often desired that the operation of such devices be carried out as unobtrusively as possible, the devices being carried, for example, in a pocket, on a belt or other support, and/or under the clothes of a user. If a bolus, a metered injection, or a single dose of medicant is to be triggered “blind”, the controls, buttons or switches required for triggering should be easy to feel, so that they may be identified and actuated under clothes or when the device not visible to the user. When certain types of switches are used, e.g., touch-pads, push-buttons, etc., it is possible for a device to be triggered randomly and unintentionally by inadvertent actuation of the switch, for example, by contact with the belt or hand when putting on a safety belt, by inadvertent impact with an object, etc.
Furthermore, in the case of medical devices to be actuated by a switch or other user input there is the risk that persons not authorized to operate the device, such as children or persons inexperienced in handling the device, inadvertently or intentionally may trigger undesired actions of the device.